drugset / Trial / NCT00437957
Phase I Study of Temozolomide, Valproic Acid and Radiation Therapy in Patients With Brain Metastases
Phase 1
Terminated
10 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Schering-Plough · collab
NaSingle-groupOpen-labelTreatment
Summary
This type of study is called a "Phase I study". Its purpose is to determine the side effects of the two medicines listed in this study when given together with whole brain radiation, and the highest dose of valproic acid that can be given together with temozolomide and whole brain radiation. We will also study the drug combination's effectiveness in treating cancer. While both of these drugs and whole brain radiation have been used in people for many years, they have never been combined for the purpose of treating patients with cancer.
Timeline
- Start
- 2006-12
- Primary completion
- 2009-04
- Completion
- 2009-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temozolomide | Small molecule | 75 mg/m2 | Oral |
| Subject | Valproic Acid | Small molecule | 20 mg/kg | Oral |
| Subject | Valproic Acid | Small molecule | 30 mg/kg | Oral |
| Subject | Valproic Acid | Small molecule | 40 mg/kg | Oral |
| Subject | Valproic Acid | Small molecule | 50 mg/kg | Oral |